Drug and Vaccine Development and Access

Abstract

This chapter explains how COVID-19 drugs and vaccines reach the market in the United States. As is always true, drug and vaccine manufacturers may seek U.S. Food and Drug Administration (FDA) approval of their products via traditional mechanisms, and pre-approval access may be granted under the expanded access or right to try pathways. In a public health emergency like COVID-19, an additional mechanism is also available: Emergency Use Authorizations (EUAs). This Chapter (1) assesses how FDA has used its EUA authorities for COVID-19 drugs and vaccines thus far, (2) considers how FDA has balanced the need for robust evidence of safety and effectiveness for COVID-19 products against the urgent need to speed patients’ access amid the clinical and political realities of the pandemic, and (3) highlights additional considerations specific to vaccines. The Chapter concludes with recommendations for policymakers and regulators at the federal and state levels, intended to improve public understanding of the regulatory process for COVID-19 drugs and vaccines, protect scientific decision making from undue political pressure, and ensure that manufacturers develop robust evidence of safety and effectiveness — and ultimately safe and effective COVID-19 countermeasures. This paper was prepared as part of the COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.